UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005913 |
|---|---|
| Receipt number | R000006992 |
| Scientific Title | Capsicam plaster at acupoint GV14 reduces the incidence of post-regional anesthetic shivering in parturients: a randomised clinical trial |
| Date of disclosure of the study information | 2011/07/04 |
| Last modified on | 2011/07/04 10:26:44 |
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Basic information
Public title
Capsicam plaster at acupoint GV14 reduces the incidence of post-regional anesthetic shivering in parturients: a randomised clinical trial
Acronym
Acustimulation with capsicum plaster for shivering treatment
Scientific Title
Capsicam plaster at acupoint GV14 reduces the incidence of post-regional anesthetic shivering in parturients: a randomised clinical trial
Scientific Title:Acronym
Acustimulation with capsicum plaster for shivering treatment
Region
| Asia(except Japan) |
Condition
Condition
obstetric patients undergoing regional (subarachnoid or extradural) anesthesia for cesarean delivery were recruited into the study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of GV14 acupoint stimulation on the incidence of post-regional anesthetic shivering
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the overall incidence and grades of post-regional anesthetic shivering
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In group A, the capsicum plaster was affixed at the GV14 acupoint.
Interventions/Control_2
In group B, a similar inactive adhesive plaster on the same point.
Interventions/Control_3
In group C, the capsicum plaster was affixed at the 5 cm of the left of GV14 acupoint.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
obstetric patients (ASA physical status I or II) scheduled for cesarean delivery under epidural anesthetic with no prior medication were included in this study
Key exclusion criteria
1, initial body temperature more than 38 centigrade or less than 36.5 centigrade.
2, hyperthyroidism, hypertension, diabetes mellitus, impaired renal or liver functions, endocrine or cardiopulmonary disease.
3, taking vasoactive or antidepressant drugs.
4, receiving intraoperative blood or blood products transfusion.
5, and known history of alcohol or substance abuse
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chen Jie |
Organization
Third Military Medical University
Division name
Department of Anaesthesiology, Southwest Hospital,
Zip code
Address
Gaotanyan road, Shapingba, Chongqing, China
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chen Jie |
Organization
Third Military Medical University
Division name
Department of Anaesthesiology, Southwest Hospital,
Zip code
Address
Gaotanyan road, Shapingba, Chongqing, China
TEL
Homepage URL
cjandsh2009@yahoo.cn
Sponsor or person
Institute
Department of Anaesthesiology, Southwest Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, Southwest Hospital,
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 04 | Day |
Last modified on
| 2011 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006992
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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